The Effect of Ultrasound on Orthodontic Tooth Movement

This study has been completed.

Sponsor:

SmileSonica Inc.

ClinicalTrials.gov Identifier:

NCT01828164

First Posted: April 10, 2013

Last Update Posted: May 22, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

Rate of Tooth Movement [ Time Frame: 24 weeks or until the extraction space was closed (whichever came first) ]

The weekly rate of tooth movement (mm/week) as compared between the treated side and the control side.

Secondary Outcome Measures:

Rate of Root Resorption [ Time Frame: 24 weeks or until the extraction space was closed (whichever came first) ]

The weekly rate of tooth root resorption (mm/week) as compared between the treated side and the control side.

Discomfort [ Time Frame: 24 weeks or until the extraction space was closed (whichever came first) ]

Average measured level of subject discomfort or pain. The Participant Pain Reporting Scale is used to assess the amount of pain on a 10 point scale. On the 10 point scale, 1 represents the least amount of pain and 10 represents the most amount of pain.

20 minutes per day of ultrasound treatment on the active side of the device. The device consists of a mouth guard type device with transducers embedded in the mouth guard. In the split mouth design, the treatment arm consist of the side of the mouth with the transducers activated.

Device: Ultrasound

The Aevo System™ is an ultrasound emitting dental device.

Other Name: Aevo System.

Sham Comparator: Control Arm

The transducers are not activated on the control side of the device.The subjects wear the device for 20 minutes per day for the duration of the study. The device consists of a mouth guard type device with transducers embedded in the mouth guard. In the split mouth design, the control arm consist of the side of the mouth with the transducers deactivated.

Device: Sham comparator

Ultrasound not activated in the comparator side of the device.20 minutes per day of ultrasound treatment on the active side of the device. The device consists of a mouth guard type device with transducers embedded in the mouth guard. In the split mouth design, the treatment arm consist of the side of the mouth with the transducers activated while the comparator arm has the transducers deactivated.

Detailed Description:

The study will involve comparing the effects of tooth movement with and without ultrasound treatment in a split mouth design. Treatment will consist of using the Aevo System™ device for one 20 minute period per day for the duration of the trial (up to 24 weeks). Tooth position measurements will be taken from eligible patients prior to commencing usage of the study device. Follow-up visits will be scheduled for intra-oral clinical measurements and to take full-arch impressions. The Aevo System™ consists of an ultrasound emitting mouthpiece which is wire connected to an external handheld device. The mouthpiece is placed over the teeth and over the braces every day for 20 minutes in order to deliver the therapy.

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

12 Years to 40 Years (Child, Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Subjects who meet all of the following criteria will qualify for entry into the study:

Scheduled to receive orthodontic treatment or in early stage of orthodontic treatment

Minimum of 3 mm of extraction space (on both sides of a dental arch) to be closed either by distal movement of all 6 anterior teeth from canine to canine or by distal movement of the canines.

Available for follow-up visits.

Willing and able to sign written informed consent.

Healthy.

Has permanent dentition and between the ages of 12 and 40.

Good oral hygiene and compliance

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from the study:

Any compromised medical or dental condition that prevents the subject from participating in the trial or using the medical device.

Any implanted assistive devices.

Currently involved in any other study.

Lives significantly outside the clinical trial site.

Use of bisphosphonates.

Pregnant females .

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828164